The purpose of this study is to evaluate a Zhineng Qigong intervention for patients with chronic low back pain and/or leg pain, and to test feasibility aspects.
Zhineng Qigong is a self-training method which enables the participant to take an active part in a possible recovery process. The aims of this study are: 1) evaluate a Zhineng Qigong intervention regarding health aspects (both subjective and objective outcomes) in patients with chronic low back pain and/or leg pain; 2) test different aspects of feasibility including recruiting from different patient populations and testing outcome measurements; and, 3) get a basis for power calculation for a future Randomised Controlled Trial. Based on previous experiences after Zhineng Qigong training with European Zhineng Qigong, this study is based on the following hypotheses: 1. Zhineng Qigong training gives pain reduction and reduced consumption of analgesics. 2. Zhineng Qigong training reduces lumbar spine-related symptoms (other than pain). 3. Zhineng Qigong training reduces healthcare utilisation, including lumbar spine surgery. 4. Zhineng Qigong training improves walking ability, mobility, and functional capacity. 5. Zhineng Qigong training improves Health-Related Quality of Life, including perceived concentration ability, distress, sleeping quality, vitality, depression, mood, and anxiety. The investigators´ idea was to give patients with chronic low back pain and/or leg pain the opportunity to practise Zhineng Qigong in an intervention arranged by European Zhineng Qigong. To this prospective interventional study without control group, patients were recruited from the Swedish spine surgery register (SweSpine), Orthopaedic clinic, and Primary Healthcare. The intervention period was 12 weeks, with measurements once before and once after intervention. However, because of difficulties in recruiting, 15 of the respondents were enrolled to 3 weeks shorter intervention, joining respondents who already started the 12 weeks intervention. Totally, 55 respondents were enrolled. Background data: * Age * Gender * Marital status * Children at home (number and age) * Duration of symptoms in the lumbar spine and/or leg (year-month when the symptoms started) * Lumbar spine diagnosis (name and year-month of the diagnosis) * History of lumbar spine surgery (number of times and which years) * Type of surgery and surgery level(s) (for postoperative patients) * Sick- or disability pension (since which year-month and main reason) * Treatments and/or training methods already tried (also for how long time) * Educational level * Occupation or living situation * Smoking habits * Financial difficulties The same physiotherapist examined the respondents once before and once after the intervention period. Two weeks before and two weeks after the intervention period, a "pain diary" was filled in by the respondents. Also, they filled in questionnaires once before and once after the intervention. During the intervention period participation in the group activities was registered on an attendance list. Every day during the intervention period and two weeks after, the respondents filled in a "training diary" with information about how much Zhineng Qigong was practised besides the group activities. The respondents that were on waiting list for lumbar spine surgery were asked by telephone if lumbar spine surgery was performed or not. This was done six months after the intervention was completed. Descriptive and analytical statistics are used to present the results.
The intervention consisted of group activities which were performed in one group, as lectures, demonstrations, and Zhineng Qigong training, all planned and led by European Zhineng Qigong. The group activities were performed during four weekends (12 hours each) and weekly training two times per week (each for two hours). Introductory lecture (two hours) was given at the evening before the first weekend. The respondents were recommended daily Zhineng Qigong training with help of an instructional training CD.
Primary Healthcare Centre Dalby
Dalby, Sweden
Primary Healthcare Centre Löddeköpinge
Löddeköpinge, Sweden
Primary Healthcare Centre Capio Citykliniken Clemenstorget
Lund, Sweden
Primary Healthcare Centre Laurentiikliniken
Lund, Sweden
Pain intensity
"Pain diary" (designed for this study) measured most usual pain intensity (NRS; 0-10) in lumbar spine and/or leg (caused by lumbar spine disorder).
Time frame: Filled in once daily during 2 weeks, directly before and directly after the intervention period, respectively
Pain symptoms
Question (designed for this study) with checkboxes for selecting common lumbar spine-related pain symptoms.
Time frame: Before intervention and as soon as possible after
Non-pain symptoms
Question (designed for this study) with checkboxes for selecting common lumbar spine-related non-pain symptoms.
Time frame: Before intervention and as soon as possible after
How often "free from pain"
Question (designed for this study) with options "Almost never" to "Completely free".
Time frame: Before intervention and as soon as possible after
How often "free from non-pain symptoms"
Question (designed for this study) with options "Almost never" to "Completely free".
Time frame: Before intervention and as soon as possible after
Change in intake of analgesics
Question (designed for this study) with options.
Time frame: At baseline concerning past 3 months, after intervention since intervention start
Change in intake of other medications
Question (designed for this study) with options.
Time frame: At baseline concerning past 3 months, after intervention since intervention start
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Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Primary Healthcare Centre Linero/Östra Torn
Lund, Sweden
Primary Healthcare Centre Måsen
Lund, Sweden
Primary Healthcare Centre Nöbbelöv
Lund, Sweden
Orthopaedic clinic, Skåne University Hospital
Malmo, Sweden
Primary Healthcare Centre Södra Sandby
Södra Sandby, Sweden
Healthcare utilisation
Number of visits to physicians, nurses, physiotherapists, occupational therapists, and others. Question designed for this study.
Time frame: At baseline concerning past 3 months, after intervention since intervention start
Performed lumbar spine surgery
Follow-up if planned surgery was performed, for respondents on waiting list for lumbar spine surgery.
Time frame: 6 months after intervention
Walking ability
The respondent walked 10 meters and back, gait performance was noted ("normal gait", "slight limping", or "severe limping").
Time frame: Before and after the intervention period
Active cervical range of motion
Flexion, extension, rotation, and lateral flexion measured using Myrin inclinometer.
Time frame: Before and after the intervention period
Active maximal functional shoulder mobility
Active shoulder flexion and "hand on neck" were measured using goniometer. "Hand on back" position was noted ("buttocks"; "lumbosacral"; "thoracolumbar"; and, "between scapulae").
Time frame: Before and after the intervention period
Passive hip mobility
Hip flexion, and external and internal rotation were measured using goniometer. Extension was assessed as normal or reduced.
Time frame: Before and after the intervention period
Finger tip-floor distance
Flexion of lumbar spine with straight knees, with direction of fingers towards the floor in front of the feet. The distance between the middle finger tips and the floor was measured using tape measure.
Time frame: Before and after the intervention period
Schober test
The respondent was asked to do a lumbar flexion with straight knees to a self-chosen range and the increased distance between two skin marks (made at level S1 and 10 centimetres cranially) was registered using tape measure.
Time frame: Before and after the intervention period
Single leg stance
A functional test for balance. The respondent lifted each foot to a standard height of 20 centimetres and tried to maintain the position for 30 seconds. Timed scores were recorded with a digital stop watch.
Time frame: Before and after the intervention period
Timed get-up-and-go
A test for functional mobility. The respondent sat in a chair and at a verbal signal, the respondent stood up without using hands and walked to a point 3 meters in front, then turned around, walked back and sat down again without using hands. Timed scores were recorded with a digital stop watch.
Time frame: Before and after the intervention period
Straight leg raising test
The flexion angle of each hip was measured using Myrin inclinometer placed on the ankle joint. Also, eventual pain radiating to the leg and/or low back pain was registered.
Time frame: Before and after the intervention period
Oswestry Disability Index version 2.1a
Questionnaire assessing spine-related disability "for today".
Time frame: Before intervention and as soon as possible after
Short Form 36 version 2
Questionnaire assessing generic Health-Related Qualify of Life (standard 4-week recall).
Time frame: Before intervention and as soon as possible after
EQ-5D-5L (including EQ VAS)
Questionnaire assessing generic Health-Related Qualify of Life "for the day".
Time frame: Before intervention and as soon as possible after
Additional aspects concerning Health-Related Qualify of Life
Questions (designed for this study) evaluating perceived concentration ability, distress, sleeping quality, energy level, sadness/depression, irritability, and tension/anxiety, respectively, "the past week" (NRS; 0-10).
Time frame: Before intervention and as soon as possible after
Recruitment rate
The percentage of enrolled patients among those who early were estimated to be eligible.
Time frame: Before intervention
Retention rate
The percentage of patients who completed the study among those who were enrolled.
Time frame: After intervention
Attendance in group activities
Attended hours in group activities were registered.
Time frame: During intervention
Individual Zhineng Qigong training time
Training diary (designed for this study) with individual daily Zhineng Qigong training time (minutes), besides group activities.
Time frame: During intervention and 2 weeks after intervention
Ability to collect outcome measures
The percentage of completed outcome measures.
Time frame: At baseline and after intervention